Care Bundle for Stroke

(I-CATCHER Trial)

Recruiting at 13 trial locations

Overseen By Trine Apostolaki-Hansson, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Region Skane

Disqualifiers: Previous care limitation, End-stage comorbidity, Brain tumor, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

3500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.

Are You a Good Fit for This Trial?

This trial is for individuals who've had a stroke caused by cerebral hemorrhage within the last 24 hours, confirmed by CT scan. It's not suitable for those with other types of strokes or conditions that might interfere with the treatment.

Inclusion Criteria

My brain bleed was confirmed by a CT scan without dye.

My symptoms started less than 24 hours ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase 1: Usual Care

Hospitals provide usual care to patients with ICH as part of the baseline period

6 months

Phase 2: Randomized Evaluation

Hospitals are randomized to either implement the Care Bundle or continue with usual care

6 months

Phase 3: Post-implementation Follow-up

All hospitals implement the Care Bundle and are monitored for sustainability and integration into routine practice

6 months

Follow-up

Participants are monitored for functional outcomes and quality of life after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• International Care Bundle

Trial Overview The study tests a 'Care Bundle' including early blood pressure control, fever and high blood sugar management, neurosurgery referral if needed, and rapid reversal of oral anticoagulation against standard care to improve outcomes after cerebral hemorrhage.

How Is the Trial Designed?

Group I: Intervention group Active Control 8 Interventions

A range of implementation methods will be used to introduce an active Care Bundle with time- and target-based metrics that involve the rapid correction of abnormal physiological variables over days or hospital discharge (or death, if sooner) and referral pathways

Group II: Usual care Placebo Group 1 Intervention

For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.

Who Is Running the Clinical Trial?

Region Skane

Lead Sponsor

Trials

369

Recruited

599,000+

The George Institute for Global Health, Australia

Collaborator

Trials

20

Recruited

50,200+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+